Valve For Short Time Replacement, For Taking Over The Function Of And/Or For Temporary Or Partial Support Of A Native Valve In A Heart And A Method For Delivery Therefor

ABSTRACT

Disclosed is a valve for short time replacement, for taking over the function of and/or for temporary support of a native valve in a heart, the valve being positioned through the native valve upon implantation, the valve comprising an at least partially collapsible and/or at least partially expandable tube and a flange. The valve allows for fast and easy replacement of a native valve, and more time for medical personnel to make decisions, prepare and/or perform surgery/medical intervention. Thus, the valve may provide for an improved quality of surgery/medical intervention.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 14/762,413 filed Jul. 21, 2015 entitled A Valve ForShort Time Replacement, For Taking Over The Function Of And/Or ForTemporary Or Partial Support Of A Native Valve In A Heart And A MethodFor Delivery Therefor, which is the U.S. National Phase of and claimspriority to International Patent Application No. PCT/EP2014/051540,International Filing Date Jan. 27, 2014, entitled A Valve For Short TimeReplacement, For Taking Over The Function Of And/Or For Temporary OrPartial Support Of A Native Valve In A Heart And A Method For DeliveryTherefor, which claims benefit of European Application No. EP13152770.7,filed Jan. 25, 2013 entitled A Valve For Short Time Replacement ForTaking Over The Function Of, And/Or For Temporary Or Partial Support Of,A Native Valve In A Heart; and U.S. Provisional Application Ser. No.61/756,649, filed Jan. 25, 2013 entitled A Valve For Short TimeReplacement, For Taking Over The Function Of And/Or For Temporary OrPartial Support Of A Native Valve In A Heart And A Method For DeliveryTherefor; all of which are incorporated herein by reference in theirentireties.

This application is related to application “A medical device and methodfor facilitating selection of an annuloplasty implant” filed 25 Jan.2013 having EP application nr: EP13152774 and U.S. provisionalapplication No. 61/756,633, application “A medical system, and a devicefor collecting chordae and/or leaflets” filed 25 Jan. 2013 having EPapplication nr: EP13152769 and U.S. provisional application No.61/756,657, application “Temporary atrium support device” filed 25 Jan.2013 having EP application nr: EP13152771 and U.S. provisionalapplication No. 61/756,663, and application “A system for cardiac valverepair” filed 25 Jan. 2013 having EP application nr: EP13152768 and U.S.provisional application No. 61/756,670. The above applications areincorporated herein by reference in their entirety for all purposes.

BACKGROUND OF THE INVENTION Field of the Invention

This invention pertains in general to the field of medical devices forimprovement of heart valves, such as mitral, aortic or tricuspid valves,as well as tools and methods therefore. More particularly the inventionrelates to a valve for short time replacement or support of a nativevalve, such as a mitral, an aortic or a tricuspid valve, in a heart anda method of delivery therefor.

Description of the Prior Art

During heart surgery, a premium is placed on reducing the amount of timeused to replace and repair valves as the heart is frequently arrestedand without perfusion.

Thus, it would be advantageous to have a short time replacement valvetemporarily replacing a native valve to be repaired or replaced duringsuch repair, replacement or preparations therefor in order to allow fore.g. a beating heart intervention.

Furthermore, since a premium is placed on reducing the amount of timeused to replace and repair valves, there is not a lot of time for makingdecisions, preparing or performing surgery or medical intervention.Thus, it would also be advantageous to have more time to make decisions,for preparations and/or for performing surgery or medical intervention.This may be important, especially since more time may lead to animproved quality of the replacement or repair.

The use of a temporary valve has been disclosed in US20070219630 A1.

In US2012/101571A1 a mitral valve prosthesis is disclosed, for replacingfailed/failing mitral valve in heart of patient. The valve prosthesis isfor permanent implantation in the ventricle of the heart only and hasmultiple components to be assembled in the heart.

In US2008/077235 A1 an inflatable balloon is disclosed for the placementand treatment of an insufficient or stenotic cardiac valve, such as themitral valve. Balloon may deflate, dislocate, punctured during delivery,etc.

In WO2012/095159 A2 a ring-shaped prosthetic valve is disclosed forpermanently replacing an atrioventricular heart valve that comprises anannular body on which valvular cusps are fastened for insertion into avalve annulus of the heart.

In US2007/255396 A1 a girdle is disclosed for surrounding the chordaetendinae of a heart valve.

In US2007/038293 A1 a device and methods for endoscopic annuloplasty aredisclosed. Opposed valve leaflets may be temporarily grasped and heldinto position prior to permanent attachment. No replacement valve isdisclosed in US2007/038293 A1.

However, as can be seen from e.g. FIGS. 5 and [0130] in this document,the temporary valve is placed away from the mitral valve. Furthermore,as can be seen in [0076] of this document, a mitral valve separationunit is needed for proper function. Moreover, the flow is in theexamples described in this document directed through conduits, such asconduits 130, 140, 330, 340, 430, 440, and thus not through the nativevalve.

The construction of the temporary valve function as a whole is thusrather complicated.

It may thus be advantageous to have a temporary valve which is of asimple, effective and cost-effective construction. Such a constructionmay utilize parts of or the whole native valve.

SUMMARY OF THE INVENTION

Accordingly, examples of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a valve for short time replacement of a nativevalve in a heart and a method of delivery therefor, according to theappended patent claims.

The invention is advantageous, since by the use of the temporary valvedisclosed herein, there may be more time for making decisions about howto perform surgery or intervention, for preparing surgery and/or forperforming surgery or medical intervention. Thus, quality of repair orreplacement of a native valve may be improved.

According to aspects of the disclosure, a valve for short timereplacement of a native valve in a heart and a method of deliverytherefor are disclosed.

According to one aspect of the disclosure, a valve for short timereplacement, for taking over the function of and/or for temporary orpartial support of a native valve in a heart is provided. The valve ispositioned through the native valve upon implantation. The valvecomprises a tube and a flange. The tube is at least partiallycollapsible. The tube may alternatively or in addition be at leastpartially expandable. The expandable flange prevents the valve frommoving out of position from the left atrium towards the left ventricleor from the ascending aorta towards the aortic arc or to the descendingaorta.

According to another aspect of the disclosure, a method of delivering avalve for short time replacement of a native valve, such as a mitralvalve, in a heart, is provided. The method comprises gainingtrans-apical or trans-aortic access to the heart or transseptal accessto the heart via a venous route for a mitral valve. The method furthercomprises forwarding a catheter, via a trans-apical route or via anaortic route, i.e. trans-catheter-based, into the left ventricle of theheart. Alternatively, the catheter may be forwarded transseptally via avenous route. During the forwarding, the catheter passes at least partlythrough the native valve. Thereafter the valve is positioned inside thenative valve. The method may also comprise pulling a plurality ofchordae together and towards the valve for fixation of the valve.Furthermore, the method may comprise deploying of a clip to surround thevalve and/or to keep the chordae in position towards the valve. Themethod also comprises removing the catheter.

Further examples of the disclosure are defined in the dependent claims,wherein features for the second and subsequent aspects of the disclosureare as for the first aspect mutatis mutandis.

Some examples of the disclosure provide for more time for makingdecisions about how to perform surgery or medical intervention.

Some examples of the disclosure provide for more time for preparingsurgery.

Some examples of the disclosure provide for more time for performingsurgery or medical intervention.

Some examples of the disclosure provide for an improved quality ofrepair or replacement of a native valve.

Some examples of the disclosure provide for a simple and/or a reliabletemporary valve function.

Some examples of the disclosure provide for that the tube does notinterfere with any annuloplasty device or similar device.

Some examples of the disclosure provide for reliable securing of thetemporary valve.

Some examples of the disclosure provide for fast and/or easy replacementof a native valve.

Some examples of the disclosure provide for fast and/or easy positioningof a temporary valve.

Some examples of the disclosure provide for that simple and/or fastdeployment of a clip is enabled.

Some examples of the disclosure provide for a fast and easy collectionof chordae.

Some examples of the disclosure provide for fast and easy securing ofthe temporary valve.

Some examples of the disclosure provide for fast and easy tightening tominimize paravalvular leakage.

Some examples of the disclosure provide for a procedure that is lessprone to errors and thus a faster and easier securing of the valve.

Some examples of the disclosure provide for reliable securing of atemporary valve and/or chordae.

Some examples of the disclosure enable precise positioning of an implantor a valve in the anatomically correct position.

Some examples of the disclosure provide for that the procedure orsurgery can be performed with high accuracy.

Some examples of the disclosure provide for an easier and/or lessinvasive delivery method.

Some examples of the disclosure provide for fast and easy collection ofchordae.

Some examples of the disclosure provide for a fast and easy way ofdelivering, positioning and/or securing a temporary valve from outsidethe body of a patient.

Some examples of the disclosure enable beating heart surgery.

Some examples of the disclosure provide for a reduced leakage.

Some examples of the disclosure provide for a minimized regurgitationduring e.g. beating heart surgery.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of examples of the present disclosure, referencebeing made to the accompanying drawings, in which

FIG. 1A is a cross-sectional view of a patient with a heart;

FIG. 1B is a perspective view of a mitral valve and an aortic valve;

FIG. 2 is a schematic cross-sectional view of a mitral valve;

FIG. 3A is a cross-sectional view of a mitral valve with a catheterinserted into the left ventricle;

FIG. 3B is a schematic cross-sectional view of an aortic valve with acatheter inserted into the aortic arc and partly into the ascendingaorta;

FIG. 4A is a schematic cross-sectional view of a mitral valve with acatheter partly in the left atrium;

FIG. 4B is a schematic cross-sectional view of an aortic valve with acatheter partly in the ascending aorta;

FIG. 5A is a schematic cross-sectional view of a mitral valve with avalve being delivered;

FIG. 5B is a schematic cross-sectional view of an aortic valve with avalve being delivered;

FIG. 6A is a schematic cross-sectional view of a mitral valve with avalve for short time replacement of the mitral valve;

FIG. 6B is a schematic cross-sectional view of an aortic valve with avalve for short time replacement of the aortic valve;

FIG. 7A-C are schematic illustrations of a principle of a valve forshort time replacement of a native valve;

FIGS. 8A-B are schematic perspective views of a collecting unit forcollecting and arranging chordae towards a valve;

FIG. 9 is a schematic view of a clip used to secure a valve;

FIGS. 10 and 11 are schematic perspective views of various collectingunits for collecting and arranging chordae towards a valve;

FIGS. 12A-B are schematic perspective views of a collecting unit forcollecting and arranging chordae towards a valve, which unit comprisestwo hooks, arms or balloons; and

FIGS. 13A and 13B are schematic perspective views in partialcross-section which illustrate retracting of chordae.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Specific examples of the disclosure will now be described with referenceto the accompanying drawings. This invention may, however, be embodiedin many different forms and should not be construed as limited to theexamples set forth herein. Rather, these examples are provided so thatthis disclosure will be thorough and complete, and will fully convey thescope of the invention to those skilled in the art. The terminology usedin the detailed description of the examples illustrated in theaccompanying drawings is not intended to be limiting of the invention.In the drawings, like numbers refer to like elements.

The following description focuses on an example of the presentdisclosure applicable to a native valve of the heart and in particularto a mitral and an aortic valve. However, it will be appreciated thatthe disclosure is not limited to this application but may be applied tomany other native valves including for example a tricuspid valve or apulmonary valve.

FIG. 1A illustrates a patient 10 having a heart 12 shown incross-section including a left ventricle 14 and a right ventricle 16.The concepts of the present invention are suitable to be applied, forexample, to a mitral valve 18, which supplies blood into the leftventricle 14 or to an aortic valve 34. The tricuspid valve (15) and thepulmonary valve (17) are also shown in FIG. 1A. Native mitral valve 18,also shown in FIG. 1B, includes an annulus 20 and a pair of leaflets 22,24 which selectively allow and prevent blood flow into the leftventricle 14. Leaflets 22, 24 are supported for coaptation by chordaetendinae, chordae or chords 26, 28 extending upwardly from respectivepapillary muscles 30, 32. Blood enters the left ventricle 14 through themitral valve 18 and is expelled during subsequent contraction of heart12 through aortic valve 34. The aortic valve 34 controls blood flow tothe aorta and organs connected to the aorta. It will be appreciated thatthe present invention may also be applicable to a tricuspid heart valve(15).

FIG. 2 is a cross-sectional view of a mitral valve 18 and surroundings.The left atrium 44, the left ventricle 14, the chordae 26, 28 and themitral valve 18 can be seen in this figure.

FIG. 3A illustrates a catheter 310, which is being utilized fordelivering a valve for short time replacement of a native valve, such asthe mitral valve 18. The catheter 310 may be inserted into the leftventricle 14 of the heart in any known way. The catheter 310 is in someexamples inserted via a transapical route. In these examplestrans-apical access to the heart is gained and the catheter 310 will beforwarded, via the trans-apical route, into the left ventricle 14 of theheart.

Once the catheter has entered the left ventricle 14, the catheter isforwarded so that it is at least partly put through the mitral valve 18and partly into the left atrium 44 as illustrated in FIG. 4A. Thecatheter 310 may be the delivery system for all implements used in theprocedure. Thus, the catheter 310 may be utilized also for delivery ofchordae collection devices, commissure locating tools and/orannuloplasty devices for long-term use. Thereafter, the valve forshort-time replacement 502, which may be an artificial valve, ispositioned inside the native mitral valve 18. This is illustrated inFIG. 5A. In order to facilitate the delivery of the valve 502 and toenable the positioning of the valve 502, the valve 502 may becollapsible for delivery and/or expandable upon delivery. This may beachieved by the use of an at least partly flexible valve. As an example,a flange of the valve 502 may be flexible during delivery. Once thevalve 502 has been positioned inside the native valve, a plurality ofchordae may be pulled together and towards the valve 502 for fixation ofthe valve 502.

Pulling of a plurality of chordae together is in some examples performedfor creation of a temporary space between at least one chorda and aventricular wall of the heart. Within this temporary space, anannuloplasty device may pass for delivery. Thus, an additional space maybe created between e.g. at least two chordae and a ventricular wall ofthe heart by pulling a plurality of chordae together. Through theadditional space an annuloplasty device may be advanced into position.The insertion of an annuloplasty device is preferably performed afterthe valve 502 has been positioned.

The plurality of chordae may in some examples be pulled together byrotation or twisting of the valve 502. The rotation of the valve 502 forpulling the chordae together is preferably specified to one direction,such as anticlockwise rotation. The rotation of the valve 502 may beactuated by rotating a catheter. As an example, a two-axis steerablecatheter may be used for actuating the rotation of the valve 502.

A clip may thereafter be deployed to surround the valve 502 and/or tokeep the chordae in position towards the valve 502. In some examples,the clip is deployed by pushing it out of the catheter 310 and intoposition with a pusher or a pushing catheter. Alternatively or inaddition, the clip may be delivered with a special clip guide tube. Thecatheter 310 may thereafter be removed or utilized for inserting furtherimplants or devices, such as an annuloplasty device. The valve 502 mayremain inside the native valve during positioning of an annuloplastydevice. Once an annuloplasty device has been inserted for permanentimplantation, positioned and secured, the temporary, short-term, valve502 is removed.

FIG. 3B illustrates a catheter 310, which is being utilized fordelivering a valve for short time replacement of a native valve, such asthe aortic valve 34. The catheter 310 may be inserted via the aortic arcat least partly into the ascending aorta 52. In these examples, thecatheter enters for instance trans-femorally from the groin and goes viaaorta at least partly into the ascending aorta 52 for delivery of thevalve at the aortic valve 34.

Once the catheter has entered the ascending aorta 52, the catheter isforwarded so that it is at least partly put through the aortic valve 34and partly into the left ventricle 14 as illustrated in FIG. 4B. Thecatheter 310 may be the delivery system for all implements used in theprocedure. Thus, the catheter 310 may in addition be utilized also fordelivery of chordae collection devices, commissure locating tools and/orannuloplasty devices for long-term use. Thereafter, the valve forshort-time replacement 502, which may be an artificial valve, ispositioned inside the native aortic valve 34. This is illustrated inFIG. 5B. In order to facilitate the delivery of the valve 502 and toenable the positioning of the valve 502, the valve 502 may becollapsible for delivery and/or expandable upon delivery. This may beachieved by the use of an at least partly flexible valve. As an example,a flange of the valve 502 may be flexible during delivery. Once thevalve 502 has been positioned inside the native valve, a plurality ofchordae may be pulled together and towards the valve 502 for fixation ofthe valve 502.

Pulling of a plurality of chordae together is in some examples performedfor creation of a temporary space between at least one chorda and aventricular wall of the heart. Within this temporary space, anannuloplasty device may pass for delivery. Thus, an additional space maybe created between e.g. at least two chordae and a ventricular wall ofthe heart 12 by pulling a plurality of chordae together. Through theadditional space an annuloplasty device may be advanced into position.The insertion of an annuloplasty device is preferably performed afterthe valve 502 has been positioned.

The plurality of chordae may in some examples be pulled together byrotation or twisting of the valve 502. The rotation of the valve 502 forpulling the chordae together is preferably specified to one direction,such as anticlockwise rotation. The rotation of the valve 502 may beactuated by rotating a catheter. As an example, a two-axis steerablecatheter may be used for actuating the rotation of the valve 502.

A clip may thereafter be deployed to surround the valve 502 and/or tokeep the chordae in position towards the valve 502. In some examples,the clip is deployed by pushing it out of the catheter 310 and intoposition with a pusher or a pushing catheter. Alternatively or inaddition, the clip may be delivered with a special clip guide tube. Thecatheter 310 may thereafter be removed or is alternatively utilized forinserting further implants or devices, such as an annuloplasty device.The valve 502 may remain inside the native valve during positioning ofan annuloplasty device. Once an annuloplasty device has been inserted,positioned and secured, the valve 502 is removed.

The valve 502, shown in FIGS. 6A and 6B, is for short time replacementof a native valve in a heart and the valve 502 may be positioned throughthe native valve upon implantation. The valve 502 comprises an at leastpartially collapsible and/or at least partially expandable tube 602.Furthermore, the valve 502 comprises a flange 604. The flange 604 may beflexible during delivery, and is preferably somewhat rigid once thevalve 502 has been implanted. The flange 604 prevents the valve 502 frommoving out of position from e.g. the left atrium 44 towards the leftventricle 14 if the valve is for the mitral valve 18 and from moving outof position from e.g. the ascending aorta towards the aortic arc if thevalve is for the aortic valve 34.

In some examples, the valve 502 is a one-way valve comprising a tube 602having an inlet side 704 and an outlet side 706. This is depicted inFIG. 7A-C. The tube 602 may be flexible. This may be advantageous, sincethe use of a flexible tube prevents interference between the tube 602and annuloplasty devices. Alternatively, the tube 602 may be rigid or atleast somewhat rigid. The valve 502 may further comprise a flexibleinner sleeve 702 attached to an inlet side 704 of the tube 602 andpositioned inside the tube 602. This is depicted in FIG. 7A. Theflexible inner sleeve 702 may be made of a flexible material such asrubber. In FIG. 7A, the pressure inside the tube 602 is similar to thepressure at the inlet side 704 of the tube 602. Therefore, the flexibleinner sleeve 702 has more or less a same pressure on an inside of thesleeve 702 which is in contact with the inlet side 704, as on an outsideof the flexible inner sleeve 702 which is in contact with the outletside 705, thus making the valve partly open. In FIG. 7b the pressureinside the tube 602 has increased so that the pressure inside the tube602, outside of the flexible inner sleeve 702 and in the left ventricle14 is larger than the pressure at the inlet of the tube 602, inside ofthe flexible inner sleeve 702 and the left atrium 44. When the pressureinside the tube 602 becomes higher than the pressure at and/or outsidethe inlet of the tube, the valve 502 closes by the flexible inner sleeve702 contracting together. In FIG. 7C the pressure inside the tube 602and outside of the flexible inner sleeve 702 is lower than the pressureat or outside the inlet of the tube 704 and inside of the flexible innersleeve 702. When the pressure inside the tube 602 becomes lower than thepressure at or outside the inlet of the tube, the valve 502 and flexibleinner sleeve 702 opens. Thus, a simple, yet reliable replacement valveis obtained by the construction of a valve 502 as illustrated in FIGS.7A-7C. The flange 708 can also be seen in FIG. 7A. The flange 708 may beexpandable. In one example, the flange 708 is an expandable balloon.

FIG. 8A illustrates an example, wherein a collecting unit 802 isutilized for collecting and arranging chordae towards the valve 502. Thecollecting unit 802 may together with the tube 602 form one integralpart. Alternatively, the collecting unit 802 may be attachable orattached to the tube 602. In some examples, the collecting unit 802comprises a single arm or a single hook. Alternatively or in addition,the collecting unit 802 comprises a ring and/or a fluid-filled balloon.A collection unit 802 comprising a fluid-fillable or fluid-filledballoon 804 is depicted in FIG. 8B. The collection unit 802 may inaddition to the fluid-fillable or fluid-filled balloon 804 comprise asingle arm.

In some examples the valve 502 comprises the collecting unit 802 forcollecting and arranging chordae towards the valve 502. The valve may besecured, held and/or stabilized in a desired position by the collectingand arranging of chordae towards the valve 502. Thus, a reliablesecuring of the valve 502 may be achieved.

By the use of a collecting unit 802, fast and easy replacement of anative valve may be achieved. Furthermore, fast and easy positioning ofa temporary valve may be obtained. Therefore, the use of a collectingunit may contribute to give more time to make decisions related tosurgery, more time to prepare for surgery and/or more time to performsurgery or medical intervention. Thus, overall quality of valvereplacement or repair may be improved. The securing of the valve withchordae together with the shape of the valve 502 and a correctdimensioning of the valve 502 may be advantageous, since a valve withproper dimensions secured by the chordae does not press against anyventricular wall. Thus, there will be no damage to the ventricularwalls. Although, there may be a small leakage outside the valve 502,this may be acceptable for a short period of time, such as minutes,hours or a few days.

The valve may thus in certain examples include a collecting unit forcollecting and arranging chordae towards the valve. The valve is thussecured, held and/or stabilized in a desired position by the collectingunit and arranging of chordae towards said valve. In an example thecollecting unit includes a clip, wherein the chordae and/or leaflets arekept in position towards the valve with said clip. The clip may form ahelix. The clip, in particular when in form of a helix, may be integralwith or connected to the collecting unit and not a separate piece.Hence, in some examples, the collecting unit 802 may comprise a clip.FIG. 9 illustrates such a clip 902. The chordae are kept in positiontowards the valve 502 with the clip 902. The clip 902 may be formed as aring or ring-like structure. Alternatively, the clip 902 may be formedor shaped as a helix. Thereby, the clip 902 can easily be rotated intoposition. Rotation is preferably made together with the valve when thecollecting unit, such as a clip, in particular when in form of a helix,is integral with the collecting unit. The chordae and/or leaflets arethe kept in position towards the valve with said collecting unit andsecured with said clip. This may be advantageous, since a simple and/orfast deployment of the clip 902 is enabled thereby. Furthermore,reliable securing, simple and/or fast deployment of a clip is enabled.Alternatively, when the clip, in particular when in form of a helix, isa separate piece and not integral with or unconnected with the valve,the collecting unit may be rotated separately into position. The clipmay then be applied to the collecting unit for securing the latter inposition at the chordae and/or leaflets.

FIG. 10 illustrates a valve 502 having a collecting unit for collectingand arranging chordae towards the valve 502 according to some examples.In these examples the collecting unit is shaped as a ring or ring-likestructure. The ring-shaped unit 1002 may be extended to a rod-likestructure for delivery and changeable into a ring-like structure upondelivery or implantation. Thus, it may be advantageous to have acollecting unit shaped as a ring, since it may facilitate delivery.

FIG. 11 illustrates a valve 502 having a collecting unit for collectingand arranging chordae towards the valve 502 according to some examples.In these examples the collecting unit is a fluid-filled balloon 1102.The fluid-filled balloon 1102 may be ring-like The use of a fluid-filledballoon 1102 as a collecting unit may be advantageous, since the use ofa balloon facilitates delivery and since fluid may be used to stabilizethe balloon and/or give some rigidity to the balloon. In one example,the balloon is filled with fluid upon or after delivery at the nativevalve.

FIG. 12A illustrates a collecting unit for collecting and arrangingchordae towards the valve 502 according to some examples. In theseexamples the collecting unit comprises two hooks 802, 1202 or arms.Alternatively, the collecting unit comprises a plurality, such as four,of hooks or arms. The hooks or arms are preferably positionedequidistantly around the valve 502, i.e. the hooks or arms arepreferably equidistantly distributed exteriorly along the valve 502. Acollection unit comprising two fluid-fillable or fluid-filled balloons804, 1206 is depicted in FIG. 12B. The collection unit may in additionto the fluid-fillable or fluid-filled balloons 804, 1206 comprise twoarms. Alternatively, the collecting unit comprises a plurality, such asfour, of fluid-fillable or fluid-filled balloons. The fluid-fillable orfluid-filled balloons are preferably positioned equidistantly around thevalve 502, i.e. the fluid-fillable or fluid-filled balloons arepreferably equidistantly distributed exteriorly along the valve 502.

In some examples, the collecting unit collects and arranges the chordaetowards the valve 502 during rotation of the valve 502. The rotation ispreferably anticlockwise rotation. The rotation of the valve 502 may beactuated by rotating a catheter, such as a two-axis steerable catheter.Thus, fast and easy collection of chordae may be achieved. Furthermore,fast and easy securing of the valve may be achieved. In addition, with asteerable catheter, fast and easy collection of chordae from outside thebody of a patient may be achieved. Moreover, by specifying a directionof rotation, such as clockwise or anticlockwise, a procedure that isless prone to errors, and thus a faster and easier securing of thevalve, may be obtained. In addition, reliable securing of the valve 502and the chordae may be achieved.

In some examples, the valve 502 comprises a collecting unit forcollecting and arranging leaflets towards the valve 502. In theseexamples, the valve 502 is secured, held and/or stabilized in a desiredposition by the collecting and arranging of leaflets towards the valve502. In one example, the valve 502 is secured, held and/or stabilized ina desired position by the collecting and arranging of leaflets towardsthe valve 502 and by the collecting and arranging of chordae towards thevalve 502. In some examples, the valve comprises a collecting unit forcollecting and arranging chordae and leaflets towards the valve 502.

FIGS. 13A and 13B illustrate retracting of chordae. FIG. 13A illustratesretracting of chordae with a collection unit comprising a hook, an armor a wire. A first end of a steerable catheter or wire 1310 exits a sidelumen 1302 of the delivery catheter 310. The steerable catheter 1310 isthen moved and manipulated by a user so as to surround the chordae 1340,without touching any ventricular wall 1320. The end of the catheter 1310moves in a radial direction away from the delivery catheter 310 towardsthe ventricular wall 1320 as it is advanced and/or rotated. Once thecatheter 1310 has encircled all the chordae 1340 and 360 degree coverageof the space is achieved, an end unit of the steering catheter or wire1310 is activated to pull the chordae 1340 together. Activation mayinclude rotation of the catheter or valve 502 whereupon the curvature ofthe end of the catheter having grasped the chordae pulls them togethertowards the valve. The delivery catheter 310 is held stationary duringthe whole deployment of the steerable catheter or wire 1310.

FIG. 13B illustrates retracting of chordae 1340 with a collection unitcomprising two fluid-fillable or fluid-filled balloons. The deliverycatheter 310 has two side lumens, which are equidistantly distributedaround the delivery catheter 310, i.e. 180 degrees apart. The twoballoon catheters 1330, 1332 exits the side lumens of the deliverycatheter 310. The balloon catheters 1330, 1332 are then manipulated andmoved towards a ventricular wall 1320 past the chordae 1340. Once thetwo balloon catheters are in position between the ventricular wall 1320and the chordae 1340, the balloons may be inflated or filled with afluid. When the balloons have been inflated or filled with a fluid, theballoons will fill the space between the ventricular wall 1320 and thechordae 1340 and press the chordae 1340 away from the ventricular walland towards the centre and towards each other, i.e. the balloons willencapsulate the chordae 1340 and tighten the native valve and bring thechordae 1340 towards the delivery catheter 310. The surfaces of theballoons may be provided with grooves, which form hollow channels whenthe balloons are fully inflated or fluid-filled. These channels may thenguide a ring or a replacement valve during deployment. Below, a medicalsystem for short time replacement and repair of a native valve isdescribed. The medical system comprises a valve 502. The valve 502 is inthese examples an artificial valve. Furthermore, the medical systemcomprises a device for collecting and arranging chordae to hold and/orstabilize the artificial valve in a desired position. The devicecomprises a unit for grasping a plurality of chordae. With the medicalsystem a fast and easy replacement of a native valve may be achieved.Furthermore, fast and easy positioning of a temporary artificial valvemay be achieved. Moreover, use of the medical system may contribute togive more time to make decisions related to surgery, more time toprepare for surgery and/or more time to perform surgery/medicalintervention. Thus, overall quality of e.g. valve replacement may beimproved.

In some examples, the medical system comprises a steerable catheter fordelivering the artificial valve; an annuloplasty device, which may beused to perform annuloplasty, i.e. to reshape the valve annulus, inorder to improve the function of the valve; a location valve expanderand/or a clip for locking the chordae in positions towards theartificial valve. This may enable fast and easy replacement of a nativevalve. Furthermore, it may enable fast and easy positioning of atemporary artificial valve.

Below, a device for collecting and arranging chordae to hold and/orstabilize an artificial valve in a desired position is described. Thedevice may be a medical device, and comprises a unit for grasping aplurality of chordae. With the device, a fast and easy replacement of anative valve may be achieved. Furthermore, fast and easy positioning ofa temporary artificial valve may be achieved. Moreover, use of themedical system may contribute to give more time to make decisionsrelated to surgery, more time to prepare for surgery and/or more time toperform surgery/medical intervention. Thus, overall quality of e.g.valve replacement may be improved.

In some examples, the unit for grasping a plurality of chordae comprisesan arm, a hook, a ring and/or a fluid-filled balloon. These examplesprovide for an easy way of grasping and/or collecting the chordae.

In some examples, the artificial valve is collapsible for delivery.Alternatively or in addition, the artificial valve may be expandableupon delivery. Furthermore, the device may be attachable to orintegrable with the artificial valve. Thus, the device may be attachedto or integrated with the artificial valve. These examples provide foran easier and less invasive delivery.

In some examples, the unit for grasping a plurality of chordae comprisesa plurality of hooks. The number of hooks may be three, four or anyother suitable number. Preferably, the hooks are positioned on oppositesides of the artificial valve. The hooks may also be equidistantly orsymmetrically distributed exteriorly along the artificial valve.

In some examples, the catheter 310 enters from the groin and goes via avenous route transseptally to the right atrium 44 for delivery of thevalve 502.

The medical system described herein may be utilized for short-termreplacement of a native valve and/or for temporary use during beatingheart surgery. The device described herein may be utilized forshort-term replacement of a native valve and/or for temporary use duringbeating heart surgery. The valve 502 may be utilized during beatingheart surgery. Thus, the system, the device and/or the valve 502 mayenable beating heart surgery. Furthermore, the valve 502 may be utilizedduring life saving intervention, intervention in acute leaflet and/orchordate rupture.

The system, the device and or the valve 502 may provide for a reducedleakage and/or a minimized regurgitation during e.g. beating heartsurgery. Furthermore, the system, the device and or the valve 502 mayenable precise positioning of an implant or valve 502 in theanatomically correct position. Moreover, the procedure used fordelivering a valve 502 described herein enables high accuracy ofdelivery, positioning and securing of a temporary valve 502.

Within this disclosure the term short-time or short-time replacement hasbeen used. Short-term replacement and/or repair of native valves isconsidered to be a temporary replacement. Such a temporary replacementmay be a replacement that last for minutes, hours or possibly up to afew days. Short-term replacement includes non-indwelling, i.e.non-permanently implanted, devices and methods described herein.Short-term replacement devices are intended to be removed from the bodyafter use. With a long-time replacement is herein meant a replacement,which last for several days, weeks, months or longer. Such a long-timereplacement may be made with devices intended to be permanentlyimplanted and not removed from the body, such as indwelling annuloplastydevices. Structural requirements for such devices are thus different forshort-term use and long-term use.

As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless expressly stated otherwise. Itwill be further understood that the terms “includes,” “comprises,”“including” and/or “comprising,” when used in this specification,specify the presence of stated features, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, integers, steps, operations,elements, components, and/or groups thereof. It will be understood thatwhen an element is referred to as being “connected” or “coupled” toanother element, it can be directly connected or coupled to the otherelement or intervening elements may be present. Furthermore, “connected”or “coupled” as used herein may include wirelessly connected or coupled.As used herein, the term “and/or” includes any and all combinations ofone or more of the associated listed items.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. It willbe further understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

The present disclosure has been described above with reference tospecific examples. However, other examples than the above described areequally possible within the scope of the disclosure. Different methodsteps or a different order thereof than those described above may beprovided within the scope of the disclosure. The different features andsteps of the disclosure may be combined in other combinations than thosedescribed. The scope of the disclosure is only limited by the appendedpatent claims.

1. An artificial valve for taking over the function of a native valve ina heart, the artificial valve is configured for being positioned throughthe native valve upon implantation, the artificial valve comprising anat least partly collapsible and/or at least partly expandable tube, aflange for preventing the artificial valve from moving out of position,a collecting unit for collecting and arranging chordae of the hearttowards the artificial valve, whereby the artificial valve is secured ina desired position by the collecting unit.
 2. An artificial valveaccording to claim 1, wherein the collecting unit is rotatable intoposition at the artificial valve.
 3. An artificial valve according toclaim 1, wherein the collecting unit comprises a clip shaped as a helix,wherein the chordae are kept in position towards the artificial valvewith the helix-shaped clip.
 4. An artificial valve according to claim 3,wherein the clip is a separate piece and not integrated with theartificial valve.
 5. An artificial valve according to claim 1, whereinthe flange is expandable.
 6. An artificial valve according to claim 1,wherein the flange is flexible.
 7. An artificial valve according toclaim 1, comprising a steerable delivery catheter having a lumen, thecollecting unit comprises a wire to be arranged in the steerabledelivery catheter to exit the lumen and surround the chordae.
 8. Anartificial valve according to claim 7, wherein the wire comprises an endunit to pull the chordae together towards the artificial valve uponactivation of the end unit.
 9. An artificial valve according to claim 7,wherein the wire is steerable.
 10. An artificial valve according to anyof claims 7-9, wherein the delivery catheter is steerable to bepositioned around the chordae.
 11. A method of delivering an artificialvalve for taking over the function of a native valve in a heart, themethod comprising gaining trans-apical, trans-septal, or trans-aorticaccess to the heart, forwarding a catheter, via a trans-apical route,via an aortic route, or transseptally, positioning the artificial valveinside the native valve with the catheter, pulling a plurality ofchordae of the heart towards the artificial valve for fixation of theartificial valve.
 12. Method according to claim 11, comprising deployinga collecting unit to surround the artificial valve to keep the chordaein position towards the artificial valve.
 13. Method according to claim12, comprising rotating the collecting unit into position to surroundthe artificial valve.
 14. Method according to claim 12, wherein thecollecting unit comprises a clip shaped as a helix, wherein the chordaeare kept in position towards the artificial valve with the helix-shapedclip.
 15. Method according to claim 11, comprising creating a spacebetween the chordae and a ventricular wall of the heart by pulling theplurality of chordae towards the artificial valve.
 16. Method accordingto claim 12, wherein the collecting unit comprises a wire, and thecatheter is a steerable catheter having a lumen, the method comprisingarranging the wire in the catheter to exit the lumen, and surroundingthe chordae with the wire.
 17. Method according to claim 16, comprisingpulling the chordae together towards the artificial valve uponactivation of an end unit of the wire.
 18. Method according to claim 12,comprising steering the catheter and/or wire into a position surroundingthe artificial valve.